Measuring Efficacy of an Oral-Irrigator After Three Weeks of Use

NCT ID: NCT04899440

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2021-06-24

Brief Summary

The primary objective of this exploratory study is to evaluate the efficacy of an Oral Irrigator in the reduction of gingivitis compared to a negative control over a 3 week period by using the Modified Gingival Index and the Gingival Bleeding Index. The secondary objective is to evaluate the efficacy of an Oral Irrigator in the reduction of plaque compared to a negative control using the extended Turesky Modified Quigley-Hein Index (TQHPI) after 3 weeks of use.

Detailed Description

This is a single-center, examiner-blind, three (3) week, two (2) treatment, parallel group, randomized study design. Thirty (30) subjects who have shown evidence of gingivitis and plaque will be enrolled in this study. Subjects will be evaluated for gingivitis using the Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI) and evaluated for plaque using the Turesky Modified Quigley-Hein Plaque Index (TQHPI) at two (2) time points: Baseline and after three (3) weeks of product use. Qualified subjects will be stratified and randomly assigned to one of the two treatment groups, toothbrushing on conjunction with an Oral Irrigator or toothbrushing without an Oral Irrigator (N=15/treatment). Subjects will be instructed to brush twice a day for approximately three (3) weeks with their assigned products and return for plaque and gingivitis measures at approximately three (3) weeks after the Baseline visit.

Conditions

Gingivitis; Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test Regimen

Oral Irrigator + Manual toothbrush + toothpaste Subjects will brush their teeth twice daily and will use the oral irrigator once in the evening daily

Group Type: EXPERIMENTAL

Water Flosser

Intervention Type: DEVICE

A pressurized stream of water to reduce gingivitis and remove adherent plaque

Control Regimen

Manual toothbrush + toothpaste Subjects will brush their teeth twice daily

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

No Oral Irrigator Control

Interventions

Water Flosser

A pressurized stream of water to reduce gingivitis and remove adherent plaque

Intervention Type: DEVICE

Control

No Oral Irrigator Control

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Give written informed consent and receive a copy of the signed Informed Consent form;
• Be at least 18 years of age;
• Typically use a manual toothbrush;
• Be in good general health as determined by the investigator/designee based on a review/update of their medical history;
• Possess a minimum of 16 scorable teeth (excluding third molars) with facial and lingual scorable surfaces;
• Have a Baseline MGI score between 1.75 and 2.5;
• Have a Baseline TQHPI score of at least 2.00;
• Have a Baseline between 20 and 80 Bleeding sites;
• Abstained from all oral hygiene procedures for approximately 12 hours prior to this visit and agree to do the same prior to the subsequent visit;
• Abstained from eating, drinking*, chewing gum and using tobacco for at least 4 hours prior to this visit and agree to do the same prior to the subsequent visit. *(Exception: Allowed small sips of water up until 45 minutes prior to their appointment time.)
• Agree not to participate in any other oral care study for the duration of this study;
• Agree to delay any elective dentistry, including dental prophylaxis, and to report any non-study dentistry received during the course of this study;
• Agree to refrain from using any non-study toothbrushes, dentifrices, mouth rinses, tooth whitening products or floss for the study duration; and
• Agree to return for their scheduled visits and to follow all study procedures.

Exclusion Criteria

• Hypersensitivity to dyes;
• Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
• Any carious lesions requiring restorative treatment;
• Active treatment for periodontitis;
• Any fixed facial orthodontic appliances or retainers;
• Use of any antibiotic medication or a prescription mouth rinse any time within the 2 weeks prior to study initiation; or
• Any disease or conditions that could be expected to interfere with examination; procedures or the subject safely completing the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Salus Research

Fort Wayne, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021043

Identifier Type: -

Identifier Source: org_study_id